July/August 1999
Volume 19, Number 4

Theme: Documentation

Table of Contents

Articles

Pharmaceutical Engineering Interviews Mr. Masayoshi Onoda by Masayoshi Onoda Pharmaceutical Engineering Interviews Mr. Masayoshi Onoda, President and CEO, Yamanouchi Pharmaceutical Co., Ltd. Download Article...

A Modified Laboratory Size Rotary Fluidized-Bed for Pharmaceutical Solid Materials Processing by Emir Nirun, Murat Yeniyurt & Murat Turkoglu, PhD Design, construction, and testing of laboratory size rotary fluidized bed. Download Article...

Project Programming to Start-Up by Erlinda M. Medina Presentation of a streamlined method for managing projects, as they evolve from conceptual study through start-up. Download Article...

GAMP Applied to Packaged Systems "Bringing GAMP Down to the Factory Floor" by The JETT Consortium The JETT Consortium is promoting validation procedures and documentation standards for packaged equipment. Download Article...

Validation of a Water System for the 21st Century by Nissan Cohen This article presents alternatives to traditional validation methods. Download Article...

Characterization of a Pharmaceutical Wet Granulation Process in a V-Type Granulator by Thomas S. Chirkot The influence of binder strength and agitator speed on the granulation process in a V-Type granulator is assessed. Download Article...

Validation Protocols by Jay Cantwell This article identifies and defines the key elements to be considered in the IQ and OQ qualification protocol. Download Article...

Specifying a Batch Management System for Electronic Records and Signatures - A Checklist for Compliance with 21 CFR Part 11 by Janice Abel & Larry LeBlanc This article provides a checklist for evaluating Electronic Batch Record (EBR) systems for compliance with recent FDA regulations governing use of electronic records and signatures in documenting batch processes. Download Article...